Testing the Elevation as Sleep Apnea Treatment (TEST)

• ClinicalTrials.gov Identifier: NCT02088723
• Recruitment Status: Completed
• First Posted: March 17, 2014
• Last Update Posted: October 20, 2015
• Sponsor: Pulmonar
• Information provided by (Responsible Party): Pulmonar

Study Description

Brief Summary:

The purpose of this study is to determine if the elevation of the head of the bed in patients with obstructive sleep apnea can decrease the apnea-hypopnea index. First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.

Condition or disease	Intervention/treatment	Phase
Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep	Behavioral: Head of bed elevation	Not Applicable

Detailed Description:

There are many researches that demonstrate that the position of the patient modified the apnea-hypopnea index(IAH). In supine position the IAH will increase comparing with lateral position during th sleep. However few studies were done with the elevation of the head of the bed.

First the investigators will do a standard polysomnography and see if the patients are included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do the second polysomnography but this will be with a elevation of the head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators will compare the data of apnea-hypopnea index in the standard polysomnography versus the index with the elevation of the head of the bed.The main outcome will be to analyze the apnea hypopnea index comparing standard polysomnography (sPSG) with elevated polysomnography (ePSG).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Influence of Elevation of the Head of the Bed in Patients With Obstructive Sleep Apnea
• Study Start Date: September 2014
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: head of bed elevation; Compare the apnea hypopnea index with the patient in standard polysomnography and in elevated polysomnography (head of bed elevation)	Behavioral: Head of bed elevation; head of bed elevation elevation the head of the bed with 15 cm (head of bed elevation) and compare the apnea-hypopnea index with the standard polysomnography

Outcome Measures

Primary Outcome Measures :

1. Apnea-Hypopnea Index compared by the polysomnography standard versus polysomnography with the elevation of the head of the bed [ Time Frame: The difference between the first exam to the second will be 2 weeks. ]
   During the polysomnography there are sensors that detect the airflow by cannula pressure and thermistor. WIth those equipment during the all night the patient will be registered and seen if there is absence of flow (apnea) and/or reduction of flow (hypopnea). The apnea and hypopnea index is done by dividing the number of respiratory events by recording time in hours of sleep (events per hour).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Berlin questionnaire high risk
• Epworth score > 9
• Obstructive Sleep Apnea with an index ≥ 5 events/hour on the polysomnography (The American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events: rules,terminology and technical specifications. American Academy of Sleep Medicine, 2012)

Exclusion Criteria:

• younger than 18 years and older than 80 years
• BMI more than 40 Kg/m2
• heart failure
• renal failure
• uncontrolled respiratory disease
• uncontrolled neurological disease

Contacts and Locations

Locations

Brazil

PULMONAR

Criciúma, Santa Catarina, Brazil, 88811-503

Sponsors and Collaborators

Pulmonar

Investigators

• Principal Investigator: Fábio José FB Souza, MD MSc; Pulmonar

More Information

• Responsible Party: Pulmonar
• ClinicalTrials.gov Identifier: NCT02088723
• Other Study ID Numbers: Apnea-PULMONAR-1
• First Posted: March 17, 2014
• Last Update Posted: October 20, 2015
• Last Verified: October 2015

Keywords provided by Pulmonar:

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Polysomnography; Sleep; Patient Positioning

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases